ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS

Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Approval P030029

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the advia centaur anti-hbs readypack reagents and advia centaur anti-hbs readypack calibrators. The device is indicated for the qualitative determination of total antibodies to hepatitis b surface antigen in human serum or plasma (edta or heparinized) using the advia centaur system. The assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology in unknown.

Device	ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
Classification Name	Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Generic Name	Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS
Date Received	2003-07-02
Decision Date	2004-05-14
Notice Date	2005-01-21
PMA	P030029
Supplement	S
Product Code	LOM
Docket Number	05M-0025
Advisory Committee	Microbiology
Expedited Review	No
Combination Product	No
Applicant Address	SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032
Summary:	Summary of Safety and Effectiveness
Labeling:	Labeling
Approval Order:	Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P030029		Original Filing
S013	2012-03-26	Normal 180 Day Track No User Fee
S012	2011-02-16	30-day Notice
S011	2010-09-29	30-day Notice
S010
S009	2009-09-28	Normal 180 Day Track
S008	2009-08-21	30-day Notice
S007	2009-05-18	Normal 180 Day Track
S006	2009-03-31	Normal 180 Day Track
S005	2009-03-03	Normal 180 Day Track No User Fee
S004	2008-09-18	Normal 180 Day Track
S003	2008-08-11	Normal 180 Day Track
S002
S001	2007-03-14	135 Review Track For 30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00630414471860	P030029	000
00630414471914	P030029	003